Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis (UC) Clinical Trial

Official title:

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065622
• Other study ID #: M14-033
• Secondary ID: 2013-001682-16
• Status: Completed
• Phase: Phase 3
• Start date: March 27, 2014
• Est. completion date: November 11, 2019

Study information

• Verified date: September 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 952
• Est. completion date: November 11, 2019
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy during Screening period.

• Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent or prior treatment with a full and adequate course, in the opinion of the Investigator, with oral corticosteroids or immunosuppressants or both. Mayo Score is confirmed by central reader.

Exclusion Criteria:

• Subject with Crohn's disease (CD) or indeterminate colitis (IC).

• Current diagnosis of fulminant colitis and/or toxic megacolon.

• Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.

• Chronic recurring infections or active tuberculosis (TB).

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis (UC)

Intervention

Drug:
• Adalimumab

Other:
• Placebo

Locations

Country	Name	City	State
Austria	Ordination Hainburg an der Don /ID# 127185	Hainburg An Der Donau
Austria	KH der Elisabethinen Linz GmbH /ID# 127184	Linz	Oberoesterreich
Austria	Universitaetsklinik fuer Innere Medizin 1 /ID# 125944	Salzburg
Austria	KH der Barmherzigen Brueder /ID# 127183	St Veit An Der Glan
Austria	Medizinische Universitat Wien /ID# 127186	Vienna	Wien
Belgium	AZ Sint-Lucas /ID# 127187	Ghent
Belgium	UZ Leuven /ID# 126739	Leuven
Belgium	CHU de Liege /ID# 126740	Liege
Canada	University of Calgary /ID# 125715	Calgary	Alberta
Canada	Zeidler Ledcor Centre /ID# 125713	Edmonton	Alberta
Canada	Qe Ii Hsc /Id# 127045	Halifax	Nova Scotia
Canada	London Health Sciences Centre /ID# 127055	London	Ontario
Canada	McGill Univ HC /ID# 127046	Montreal	Quebec
Canada	Mount Sinai Hosp.-Toronto /ID# 126590	Toronto	Ontario
Canada	Toronto Digestive Disease Asso /ID# 127075	Vaughan	Ontario
Canada	Winnipeg Regional Health Autho /ID# 125712	Winnipeg	Manitoba
Czechia	Hepato-Gastroenterologie HK s.r.o. /ID# 127188	Hradec Kralove
Czechia	ISCARE a.s. /ID# 127837	Praha 9
Denmark	Herlev Hospital /ID# 127191	Herlev	Hovedstaden
Denmark	Regionhospital Silkeborg /ID# 127190	Silkeborg
France	CHU Amiens Picardie /ID# 127194	Amiens CEDEX 1	Somme
France	CHU Estaing /ID# 127848	Clermont Ferrand
France	CHU Dijon /ID# 127861	Dijon
France	CHU de Grenoble - Albet Michal /ID# 127195	Grenoble
France	CHRU Lille - Hôpital Claude Huriez /ID# 127197	Lille CEDEX	Hauts-de-France
France	CHU Saint ELOI /ID# 169007	Montpellier Cedex 5
France	CHU de Nice /ID# 127193	Nice
France	CHU de Saint-Etienne, Hopital Nord /ID# 134490	SAINT-ETIENNE Cedex 1
France	Hopital Rangueil /ID# 127192	Toulouse
France	CHU NANCY - Hôpital Brabois Adultes /ID# 127196	Vandoeuvre les Nancy CEDEX	Meurthe-et-Moselle
Germany	Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 127203	Berlin
Germany	Gastrostudien GbR /ID# 169246	Berlin
Germany	Mross, Berlin, DE /ID# 127201	Berlin
Germany	Universitatsklinikum Frankfurt /ID# 170300	Frankfurt	Hessen
Germany	Asklepios Westklinikum Hamburg /ID# 127198	Hamburg
Germany	Universitaetsklinikum Jena /ID# 127205	Jena
Germany	Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 127199	Kiel	Schleswig-Holstein
Germany	EUGASTRO GmbH /ID# 127202	Leipzig
Germany	Universitatsklinikum Magdeburg /ID# 127200	Magdeburg
Germany	Gastro Campus Research GbR /ID# 126743	Munster
Germany	Universitatsklinik Regensburg /ID# 201265	Ratisbon	Bayern
Hungary	Magyar Elhizastudomanyi KKft. /ID# 126589	Budapest
Hungary	Pannonia Maganorvosi Centrum Kft. /ID# 127207	Budapest
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 127209	Pécs	Pecs
Hungary	Szegedi Tudomanyegyetem /ID# 127208	Szeged
Israel	Soroka University Medical Center /ID# 127213	Be'er Sheva
Israel	Hadassah University Hospital /ID# 127211	Jerusalem
Israel	Rabin Medical Center /ID# 127212	Petakh Tikva	Tel-Aviv
Israel	Kaplan Medical Center /ID# 127210	Rehovot
Israel	Tel Aviv Sourasky Medical Center /ID# 201365	Tel Aviv-Yafo	Tel-Aviv
Italy	A.O.U. Policlinico S.Orsola-Malpighi /ID# 129322	Bologna	Emilia-Romagna
Italy	Azienda Ospedaliera Spedali Civili /ID# 127236	Brescia
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 127138	Milan	Lombardia
Italy	Universita di Padova /ID# 127214	Padova
Italy	Ospedali Riuniti Villa Sofia-C /ID# 129323	Palermo
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 127216	Rome	Lazio
Italy	Policlinico Agostino Gemelli /ID# 127217	Rome	Lazio
Italy	Policlinico Univ Tor Vergata /ID# 129321	Rome
Italy	IBD Center - IRCCS Istituto Clinico Humanitas /ID# 127215	Rozzano	Milano
Italy	IRCCS Casa Sollievo /ID# 127811	San Giovanni Rotondo
Japan	Medical Hospital of Tokyo Medical and Dental University /ID# 128315	Bunkyo-ku	Tokyo
Japan	Fukuoka University Chikushi Hospital /ID# 124155	Chikushino	Fukuoka
Japan	Kyushu University Hospital /ID# 124495	Fukuoka-shi	Fukuoka
Japan	Hamamatsu South Hospital /ID# 124481	Hamamatsu-shi	Shizuoka
Japan	Hiroshima University Hospital /ID# 124496	Hiroshima-shi	Hiroshima
Japan	Saitama Medical Center /ID# 128875	Kawagoe-shi	Saitama
Japan	Aoyama Clinic /ID# 127836	Kobe-shi	Hyogo
Japan	Hidaka Clinic of Coloproctology /ID# 125477	Kurume	Fukuoka
Japan	Kurume University Hospital /ID# 125275	Kurume-shi	Fukuoka
Japan	Japanese Red Cross Kyoto Daiichi Hos /ID# 127540	Kyoto-shi	Kyoto
Japan	Kitasato Univ Kitasato Inst Ho /ID# 127001	Minato-ku	Tokyo
Japan	Kyorin University Hospital /ID# 148184	Mitaka-shi	Tokyo
Japan	Yokoyama IBD Clinic /ID# 151560	Nagoya	Aichi
Japan	Nagoya City University Hospital /ID# 124517	Nagoya-shi	Aichi
Japan	Hyogo College of Medicine College Hospital /Id# 127539	Nishinomiya-shi	Hyogo
Japan	Shiga University of Medical Science Hospital /ID# 127675	Otsu-shi	Shiga
Japan	Kitasato University Hospital /ID# 137694	Sagamihara-shi	Kanagawa
Japan	Toho University Sakura Medical Center /ID# 124497	Sakura-shi	Chiba
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124480	Sapporo-shi	Hokkaido
Japan	Susaki Kuroshio Hospital /ID# 125202	Susaki-shi	Kochi
Japan	Osaka Medical College Hospital /ID# 126451	Takatsuki-shi	Osaka
Japan	Tokyo Yamate Medical Center /ID# 125201	Tokyo
Japan	Wakayama Medical University /ID# 124635	Wakayama-shi	Wakayama
Japan	COLO-PROCTOLOGY CENTER Matsushima Clinic /ID# 148423	Yokohama	Kanagawa
Netherlands	Academisch Medisch Centrum /ID# 126741	Amsterdam	Noord-Holland
Poland	Szpital Uniwersytecki Nr 2 im. dr J.Biziela w Bydgoszczy /ID# 127141	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Medyczne LukaMed Joanna Luka /ID# 170302	Chojnice
Poland	Centrum Medyczne Sw. Lukaza /ID# 126515	Czestochowa
Poland	Centrum Medyczne Pratia Gdynia /ID# 170301	Gdynia	Pomorskie
Poland	NZOZ All-Medicus /ID# 128740	Katowice	Slaskie
Poland	C.M. Szpital Swietej Rodziny /ID# 127838	Lodz	Lodzkie
Poland	Centrum Diagnostyczno Lecznicze Barska /ID# 170304	Lodz
Poland	KO-Med Centra Kliniczne Pulawy /ID# 127219	Pulawy
Poland	H-T.Centrum Medyczne-Endoterapia /ID# 170305	Tychy	Slaskie
Poland	Centrum Zdrowia MDM /ID# 170303	Warsaw	Mazowieckie
Poland	NZOZ Vivamed /ID# 127218	Warsaw
Poland	Endoterapia PFG Sp. z.o.o. /ID# 126513	Warszawa	Mazowieckie
Romania	CMDTA Neomed SRL /ID# 127142	Brasov
Romania	Spitalul Clinic Judetean de Urgenta /ID# 125418	Cluj
Romania	Tvm Med Serv Srl /Id# 127221	Cluj
Romania	Cabinet Medical Dr. Fratila SRL, Specialitatea Medicina Interna /ID# 127002	Oradea
Romania	Institutul Clinic Fundeni /ID# 127839	Sector 2	Bucuresti
Romania	Salvo-San-Ciobanca SRL /ID# 127140	Zalau
Slovakia	Gastroenterologicka Ambulancia /ID# 125632	Bratislava
Slovakia	Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 127222	Bratislava
Slovakia	Vseobecna Nemocnica s poliklinikou Lucenec /ID# 127322	Lucenec
Spain	Hospital General Universitario de Alicante /ID# 129261	Alicante
Spain	Hospital Clinic de Barcelona /ID# 138147	Barcelona
Spain	Complejo Hospitalario Universitario de Ferrol /ID# 127840	Ferrol
Spain	Hospital Univ Dr. Negrin /ID# 127841	Las Palmas de Gran Canaria
Spain	Hosp Univ 12 de Octubre /ID# 129257	Madrid
Spain	Hospital General Universitario Gregorio Maranon /ID# 127224	Madrid
Spain	Hospital Univ de la Princesa /ID# 135828	Madrid
Spain	Hospital Universitario La Paz /ID# 127223	Madrid
Spain	Hosp Clin Univ de Valencia /ID# 170306	València
Spain	Hosp Clin Univ Lozano Blesa /ID# 129255	Zaragoza
Switzerland	Kantonsspital St. Gallen /ID# 127843	St. Gallen	Sankt Gallen
Switzerland	University Hospital Zurich /ID# 127842	Zurich	Zuerich
Ukraine	GI National Institute of Therapy named by L.T. Malaya /ID# 127231	Kharkiv	Kharkivska Oblast
Ukraine	Public Institution Kherson City Clinical Hospital named after le.le. Karabelesh /ID# 127233	Kherson
Ukraine	Municipal Clinical Hospital #8 /ID# 127235	Kiev
Ukraine	Lviv City Clinical Hospital NO.4 /ID# 127232	Lviv
Ukraine	CNPE City Hospital No.6 of Zaporizhzhia City Counsil /ID# 127137	Zaporizhzhia
United Kingdom	Western General Hospital /ID# 204801	Edinburgh
United Kingdom	St. Mark's Hospital /ID# 127226	Harrow
United Kingdom	Hull and East Yorkshire Hospitals NHS Trust /ID# 127225	Hull
United Kingdom	Norfolk and Norwich Univ Hosp /ID# 127139	Norwich	Norfolk
United Kingdom	Oxford University Hospitals NHS Foundation Trust The John Radcliffe Hospital /ID# 129324	Oxford
United Kingdom	Southampton General Hospital /ID# 127228	Southampton
United Kingdom	Royal Hampshire County Hosp /ID# 169250	Winchester	Hampshire
United Kingdom	The Royal Wolverhampton NHS Tr /ID# 127227	Wolverhampton
United States	University of Michigan Hospitals /ID# 122240	Ann Arbor	Michigan
United States	Atlanta Gastro Assoc /ID# 122336	Atlanta	Georgia
United States	University of Maryland Med Ctr /ID# 169734	Baltimore	Maryland
United States	Charlotte Gastro Hepatology /ID# 122235	Charlotte	North Carolina
United States	Erlanger Institute for Clinica /ID# 129009	Chattanooga	Tennessee
United States	MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238	Chevy Chase	Maryland
United States	Northwestern University Feinberg School of Medicine /ID# 122183	Chicago	Illinois
United States	University of Chicago /ID# 122302	Chicago	Illinois
United States	New River Valley Research Inst /ID# 127801	Christiansburg	Virginia
United States	Consultants for Clinical Res /ID# 122304	Cincinnati	Ohio
United States	Gastro Florida /ID# 170619	Clearwater	Florida
United States	Digestive Health Specialists of the Southeast /ID# 127844	Dothan	Alabama
United States	Dayton Gastroenterology, Inc. /ID# 127804	Englewood	Ohio
United States	DHAT Research Institute /ID# 170616	Garland	Texas
United States	Gastro One /ID# 122339	Germantown	Tennessee
United States	NYU Langone Long Island CRA /ID# 122177	Great Neck	New York
United States	Medical Research Ctr CT /ID# 122179	Hamden	Connecticut
United States	Biopharma Informatic Research /ID# 171150	Houston	Texas
United States	Ucsd /Id# 122313	La Jolla	California
United States	Gastro Assoc of Central GA /ID# 122318	Macon	Georgia
United States	Ctr for Digest and Liver Dis /ID# 122182	Mexico	Missouri
United States	Research Associates of South Florida,LLC /ID# 170309	Miami	Florida
United States	Froedtert & the Medical College of Wisconsin /ID# 122261	Milwaukee	Wisconsin
United States	WI Center for Advanced Res /ID# 122178	Milwaukee	Wisconsin
United States	Gastroenterology Group Naples /ID# 127806	Naples	Florida
United States	Vanderbilt Univ Med Ctr /ID# 125496	Nashville	Tennessee
United States	Icahn School of Med Mt. Sinai /ID# 127047	New York	New York
United States	Advanced Research Institute /ID# 126147	Ogden	Utah
United States	Austin Center for Clinical Research /ID# 125396	Pflugerville	Texas
United States	University of Pittsburgh MC /ID# 122331	Pittsburgh	Pennsylvania
United States	The Oregon Clinic- Gastro West /ID# 135273	Portland	Oregon
United States	Wake Research Associates, LLC /ID# 122157	Raleigh	North Carolina
United States	Mayo Clinic - Rochester /ID# 122244	Rochester	Minnesota
United States	University of Utah /ID# 122333	Salt Lake City	Utah
United States	University of Washington /ID# 169721	Seattle	Washington
United States	Louisiana Research Ctr. LLC /ID# 141655	Shreveport	Louisiana
United States	Texas Digestive Disease Consul /ID# 141677	Southlake	Texas
United States	Texas Digestive Disease Consul /ID# 141678	Southlake	Texas
United States	Gastro United of Tulsa /ID# 125436	Tulsa	Oklahoma
United States	Carle Foundation Hospital /ID# 135955	Urbana	Illinois
United States	Rocky Mountain Clinical Resear /ID# 122180	Wheat Ridge	Colorado
United States	Shafran Gastroenterology Ctr /ID# 122320	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Netherlands,  Poland,  Romania,  Slovakia,  Spain,  Switzerland,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score = 2 and no individual subscore > 1.	Week 8
Primary	Maintenance Period Primary Endpoint: Percentage of Week 8 Responders (Per FMS) With Clinical Remission (Per FMS) at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per FMS) are defined as participants with a decrease in Full Mayo score of = 3 points and = 30% from Baseline plus a decrease from baseline in the rectal bleeding subscore (RBS) = 1 or an absolute RBS = 1. Clinical remission per FMS is defined as Mayo Score = 2 and no individual subscore > 1.	Week 52
Secondary	Induction Period Ranked Secondary Endpoint 1: Percentage of Participants With Endoscopic Improvement at Week 8	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.	Week 8
Secondary	Induction Period Ranked Secondary Endpoint 2: Percentage of Participants With Fecal Calprotectin < 150 mg/kg at Week 8		Week 8
Secondary	Induction Period Ranked Secondary Endpoint 3: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response (Increase of IBDQ = 16 From Baseline) at Week 8	The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.	Week 8
Secondary	Induction Period Ranked Secondary Endpoint 4: Percentage of Participants With Clinical Response Per FMS at Week 8	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical response is defined as a decrease in FMS of = 3 points and = 30% from baseline, plus a decrease in the rectal bleeding subscore (RBS) = 1 or an absolute RBS = 1.	Week 8
Secondary	Induction Period Ranked Secondary Endpoint 5: Percentage of Participants With Endoscopic Remission at Week 8	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Endoscopic remission is defined as an endoscopy subscore of 0.	Week 8
Secondary	Induction Period Ranked Secondary Endpoint 6: Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 8	The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score = 6.	Week 8
Secondary	Induction Period Ranked Secondary Endpoint 7: Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 8	The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The IBDQ Fatigue item score range is from 1 (severe problem) to 7 (normal health). Response is defined as an increase of IBDQ Fatigue item score = 1.	Week 8
Secondary	Maintenance Period Ranked Secondary Endpoint 1: Percentage of Week 8 Responders (Per FMS) With Endoscopic Improvement at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of = 3 points and = 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) = 1 or an absolute RBS = 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.	Week 52
Secondary	Maintenance Period Ranked Secondary Endpoint 2: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders, per FMS, are defined as participants with a decrease in FMS of = 3 points and = 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) = 1 or an absolute RBS = 1.	Week 52
Secondary	Maintenance Period Ranked Secondary Endpoint 3: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders, per FMS, are defined as participants with a decrease in FMS of = 3 points and = 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) = 1 or an absolute RBS = 1. Clinical remission is defined as FMS = 2 with no subscore > 1.	Week 52
Secondary	Maintenance Period Ranked Secondary Endpoint 4: Percentage of Week 8 Remitters (Per FMS) With Clinical Remission (Per FMS) at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS = 2 with no subscore > 1. Endoscopy subscore provided by the central reader.	Week 52
Secondary	Maintenance Period Ranked Secondary Endpoint 5: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Improvement at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS = 2 with no subscore > 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. Endoscopy subscore provided by the central reader.	Week 52
Secondary	Maintenance Period Ranked Secondary Endpoint 6: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS = 2 with no subscore > 1.	Week 52
Secondary	Maintenance Period Ranked Secondary Endpoint 7: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission (Per FMS) at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS = 2 with no subscore > 1.	Week 52
Secondary	Maintenance Period Ranked Secondary Endpoint 8: Percentage of Week 8 Responders (Per FMS) With IBDQ Response (Increase of IBDQ = 16 From Baseline) at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of = 3 points and = 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) = 1 or an absolute RBS = 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.	Week 52
Secondary	Maintenance Period Ranked Secondary Endpoint 9: Percentage of Week 8 Non-Responders With Clinical Remission (Per FMS) at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 non-responders are defined as participants not meeting the criteria of response (defined as a decrease in FMS of = 3 points and = 30% from baseline, plus a decrease in the rectal bleeding subscore [RBS] = 1 or an absolute RBS = 1) at Week 8. Clinical remission is defined as a FMS = 2 with no subscore > 1.	Week 52
Secondary	Maintenance Period Ranked Secondary Endpoint 10: Percentage of Week 8 Non-Remitters With Clinical Remission (Per FMS) at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 non-remitters are defined as participants not meeting the criteria of clinical remission at Week 8. Clinical remission is defined as a FMS = 2 with no subscore > 1.	Week 52
Secondary	Maintenance Period Ranked Secondary Endpoint 11: Percentage of Week 8 Responders (Per FMS) With Endoscopic Subscore of 0 at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per Full Mayo score) are defined as participants with a decrease in Full Mayo score of = 3 points and = 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) = 1 or an absolute RBS = 1. Endoscopic remission is defined as an endoscopy subscore of 0.	Week 52
Secondary	Maintenance Period Ranked Secondary Endpoint 12: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Subscore of 0 at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS = 2 with no subscore > 1. Endoscopic remission is defined as an endoscopy subscore of 0.	Week 52
Secondary	Maintenance Period Ranked Secondary Endpoint 13: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Bowel Symptom Domain at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of = 3 points and = 30% from Baseline plus a decrease in the rectal bleeding subscore [RBS] = 1 or an absolute RBS = 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Bowel Symptom domain score range is 10 (severe problem) to 70 (normal health). Response is defined as increase of Bowel Symptom domain score = 6 from baseline.	Week 52
Secondary	Maintenance Period Ranked Secondary Endpoint 14: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Fatigue Item at Week 52	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of = 3 points and = 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) = 1 or an absolute RBS = 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Response in IBDQ fatigue item (range 1 [severe problem] to 7 [normal health]) is defined as increase of IBDQ fatigue item = 1 from baseline.	Week 52

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